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Parker Quality & Compliance

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510(k) clearance

FreezeSpray TA

FDA 510(k) source

510(k) number
K261684
Applicant
Cryosurgery, Inc.
Decision date
Sep 5, 2026
Date received
May 21, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
MLY
Device type
Vapocoolant Device
Device class
Unclassified
Advisory committee
Unknown
Statement or summary
Summary
Third party
N
Location
Nashville, TN, US